In conversation with Praxis SCI Accelerate cohort member SpineX

SpineX Co-Founder and CEO Parag Gad talks with us about SCONE™, a noninvasive neuromodulation technology that leverages cutting-edge laboratory research to aid recovery and restoration of bladder, bowel, respiration, sexual and sensorimotor function.

What led you here in terms of education, experience, and people you met along the way?

I believe that spinal cord injury is a problem that can be solved by engineering technologies.

I’m a bioengineer by training and think of the body as a machine with multiple redundancies built into it. In May 2013, I finished a PhD in Biomedical Engineering at UCLA. From there, working with Dr. Reggie Edgerton, Co-Founder of SpineX, was a natural transition from being a researcher to being in the field doing justice for the patients.

SpineX is run by a small but passionate team led by Dr. Edgerton, who is considered the ‘father of modern spinal neuromodulation.’ Over the past 25 years, he has personally mentored almost every individual developing neuromodulatory strategies related to spinal cord injury.

Working together, the glue for us is in striving towards a common goal. We want to find a modality to help people with spinal cord injury. It’s been driving us for the last decade at least. Our vision for the company is to build devices that are synergistic to patients and ones that can allow us to treat the human body as one organism rather than individual organs.

The stimulator technology acts like a hearing aid, so individuals can empty their bladder by sensation. It also makes them less spastic, reduces the size and frequency of leaks and increases bladder capacity. The result is improved overall bladder control and quality of life. It’s a global change here.

Tell us about your customers. What do they need, and how are they challenged in their current situation?

One of the highest priorities for people living with spinal cord injury is improvement in bladder and bowel function. This also has the biggest impact on their quality of life. People with spinal cord injury lose their ability to sense a full bladder. They empty their bladder by a clock and, if not emptied in time, their bladder will leak. On top of that, the bladder has low capacity.

Medications are effective in a small percentage of individuals and come with significant side effects. These side effects reduce compliance in taking the medications.

What these individuals need is a low-cost, low-risk therapy that addresses the actual problem rather than managing symptoms to improve overall bladder health and, therefore, quality of life. To address this, SpineX developed SCONE™, a spinal neuromodulator platform technology delivering proprietary waveforms of varying current to designated areas of the spine. SCONE does this in a specific sequence through hydrogel electrodes placed directly over the skin without causing any pain or discomfort to patients in a completely non-surgical manner. The stimulator technology acts like a hearing aid, so individuals can empty their bladder by sensation. It also makes them less spastic, reduces the size and frequency of leaks and increases bladder capacity. The result is improved overall bladder control and quality of life. It’s a global change here.

SCONE™ spinal cord neuromodulator (pictured above) has been recognized by FDA as a Breakthrough Device.

Tell us about your vision for your company?

The long-term vision is we change the pattern for people, so they’ll be off catheterization altogether and eliminate urinary tract infection (UTI) risk. We realized that we cannot depend on others to get this core technology to market. That was one of the key motivations that led to the formation of SpineX. For this technology to really have an impact, it has to be done commercially.

From a commercialization point of view, we have an advantage. Because the technology is non-invasive, the risk is minimal. In comparison to other technologies, none are approved for use in spinal cord injury.

Our objectives are to have this available for clinic and home use. For regulatory approvals, the clinical device has a lower bar. For home, the potential risks are much higher with stringent assessments. But to make an impact it needs to be a home-based device. We’re making it in two steps: first for the clinic, then home use.

SCONE has been recognized by the FDA as a Breakthrough Device. We’re hoping to initiate the pivotal studies for FDA clearance by early next year and we’re on course to meet the timeline.

When you have a spinal cord injury, all your systems are impacted in one way or another. Because SCONE technology is non-invasive, we can move the site of stimulation up and down the spine just by repositioning the electrodes.

Why is your solution different from what’s on the market?

All the systems of the body are interconnected. Your bladder is connected to your bowel. When you have a spinal cord injury, all your systems are impacted in one way or another. Competitor solutions have focused on improving cardiovascular function or walking. But secondary functions, like bladder and bowel, have an impact on quality of life. Because SCONE technology is non-invasive, we can move the site of stimulation up and down the spine just by repositioning the electrodes.

Let’s focus on bladder. What’s on the market now is not approved for people with SCI, while SCONE has shown to be effective for the SCI population, and we can expand to other conditions, including stroke and MS for example. We’re looking at this as a platform technology with multiple applications to improve multiple functions, but it also has broader applications to stroke, MS and cerebral palsy. We have data that shows improvements in children with cerebral palsy to walk.¹

The difference is the ability to reactivate the dormant (not dead) spinal cord. That’s what we’re tapping into: not specific nerves but a very smart network that is capable of controlling multiple functions, and we only need to provide it with the sufficient level of excitation. We can use a car metaphor. The spinal cord is like the engine of the car. The engine knows how to activate all four wheels to get the car moving.

Our current team is highly motivated, and laser focused on getting this therapy to patients. While we know the road ahead isn’t easy, we have identified targets to simplify our trajectory to achieve two goals.

What differentiates SpineX from the competition?

We believe in the 4Ts: team, technology, targets and trajectory. Our current team is highly motivated, and laser focused on getting this therapy to patients. While we know the road ahead isn’t easy, we have identified targets to simplify our trajectory to achieve two goals.

Our first goal is to get the product on the market as soon as possible. The second is to allow us to expand to other verticals (overactive bladder, stroke and cerebral palsy) and other end organs (spasticity, bowel function, sexual function etc.). We have OEM manufacturing building and testing devices. We’re in discussions with urologists about what information they are looking for and to see how the technology is useful to them. We’ve identified high density areas in the country to deploy the SCONE devices.

Our timeline to have this available on the market is early in 2023. That’s aggressive, I admit. I’m hoping we can do it based on our trajectory right now.

What is your goal with SCI Accelerate?

Our primary goal with SCI Accelerate is to identify our go-to market strategy. We haven’t done this before. We’re novices in getting a device to market. In SCI Accelerate we’re trying to understand the risks – what do we not know six months later. To have Gabe Kalmar and Arushi Raina guide us so we don’t make mistakes later is invaluable.

Working with the Praxis Consumer Engagement team has reinforced our objectives and we’ve gained a better understanding of what the consumers need. Those discussion gave us a better reality check. It’s difficult for us to imagine what having a spinal cord injury is like. The real-life experience is so valuable.

Learn more about the Praxis SCI Accelerate Cohort.

¹ Read about Spine’s first peer reviewed publication on the impact of SCONE technology on children with Cerebral Palsy